Fatigue and Sleep in Children and Adolescents With Juvenile Idiopathic Arthritis: A Cross-Sectional Study

Fatigue Clinical Trial

Official title:

Fatigue and Sleep in Children and Adolescents With Juvenile Idiopathic Arthritis: A Cross-Sectional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03618680
• Other study ID #: A29/03.Feb.2015
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: July 1, 2018

Study information

• Verified date: August 2018
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aims of this study is to primarily investigate fatigue and sleep and to secondarily examine possible relationships between disease activity, pain and functional ability in Turkish children and adolescents with Juvenile Idiopathic Arthritis (JIA).

Description:

Children with JIA become fatigued easily, experience joint inflammation, pain, limited mobility and report poor sleep quality and daytime sleepiness . It is reported in the literature that children with JIA suffer from poor sleep, parasomnias, daytime sleepiness, sleep fragmentation, cyclic alternating patterns increase, and sleep-disordered breathing compared to healthy children. Sleep was disturbed in almost half of the patients with both JIA and juvenile dermatomyositis, and that sleep disturbance and fatigue were both correlated with disease activity. Increased pain is associated with more sleep disturbance and more fatigue, and these appear to negatively influence quality of life.

So, in this study, fatigue and sleep in Turkish patients with JIA will be investigated by using specific surveys and also secondarily it will be examined possible relationships between disease activity, pain and functional ability in children and adolescents with JIA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: July 1, 2018
• Est. primary completion date: March 1, 2018
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

Inclusion criteria consisted of a diagnosis of JIA according to the International League of Associations for Rheumatology (ILAR) criteria (13), being aged between 6 - 18 years, and being able to read and write in the Turkish language. All patients were diagnosed as JIA 6 months prior to the study.

Exclusion Criteria:

• Patients were excluded from study if they had a second rheumatic or another chronic disease, a history of mental deficit or psychological problem or no acceptance for participation in the study by their families.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Fatigue
• Juvenile Idiopathic Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pediatric Quality of Life Inventory-Multidimensional Fatigue Scale	Pediatric Quality of Life Inventory-Multidimensional Fatigue Scale" (PedsQL-F) is a valid and reliable tool, and can be used to measure symptom-specific fatigue among patients with JIA . Fatigue symptoms will be assessed by the PedsQL-F which is an 18-item questionnaire and is designed to measure child and parent's perception of fatigue in pediatric patients and comprises the general fatigue scale (6 items), sleep/rest fatigue scale (6 items) and cognitive fatigue scale (6 items). Higher scores indicate higher quality of life.	baseline
Primary	Pittsburgh Sleep Quality Index	Sleep quality will be evaluated with Pittsburgh Sleep Quality Index (PSQI). PSQI is a 23 item questionnaire that generates scales reflecting daytime dysfunction, sleep latency, disturbance, duration, quality and efficiency. As the score increases, sleep quality decreases and daytime dysfunction due to sleep quality disorder increases. PSQI is composed of three main scores: total PSQI score, PSQI sub-scores and sleep quality status score. Each component is scored from 0 to 3, leading to a global PSQI score between 0 and 21, with higher scores indicating lower quality of sleep.	baseline
Secondary	Childhood Health Assessment Questionnaire	Functional ability will be assessed using The Turkish version of the Childhood Health Assessment Questionnaire (CHAQ). CIn 8 activities (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities), a number of questions were answered and scored on a scale of 0 - 3, where 0 = able to do with no difficulty, 1 = able to do with some difficulty, 2 = able to do with much difficulty, and 3 = unable to do. The mean of the 8 scores identified the CHAQ score (range, 0 - 3).	baseline